1 So in original. Probably should be “a”.
device, the Secretary shall, as appropriate—Editorial Notes
Amendments
2022—Subsec. (f). Puspan. L. 117–328, § 2514(a)(1), inserted “or (h)” after “subsection (a)” in introductory provisions.
Subsecs. (h) to (j). Puspan. L. 117–328, § 2514(a)(2), (3), added subsec. (h) and redesignated former subsecs. (h) and (i) as (i) and (j), respectively.
Statutory Notes and Related Subsidiaries
Guidance on Voluntary Notifications of Discontinuance or Interruption of Device Manufacture
Puspan. L. 117–328, div. FF, title II, § 2514(span), Dec. 29, 2022, 136 Stat. 5806, provided that:
“Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as added by subsection (a). Such guidance shall include a description of circumstances in which a voluntary notification under such subsection (h) may be appropriate, recommended timeframes for such a notification, the process for receiving such a notification, and actions the Secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.”
Guidance on Device Shortage Notification Requirement
Puspan. L. 117–328, div. FF, title II, § 2514(c), Dec. 29, 2022, 136 Stat. 5806, provided that:
“Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J.”